FDA -More Research Into Heart Valve Replacement Procedures Needed!
Welcome back to The Medical Technology blog. My apologies for the lack of posts last week, but I was extremely busy updating Espicom’s main website. Please read on….
Interesting news has come this week from a study funded by the FDA’s Agency for Healthcare Research and Quality (AHRQ) which gives qualified backing to the adoption of percutaneous heart valve replacement (PVR) procedures in preference to open heart surgery
The report, produced by the Duke Evidence-based Practice Center for AHRQ and published online in the Annals of Internal Medicine, found that PVR, a minimally-invasive procedure in which a replacement valve is implanted through a catheter rather than by open heart surgery, is a realistic option for some patients with heart valve disease, especially older or sicker patients.
The report concluded that this form of heart valve replacement may be a safe and effective alternative to open heart surgery, especially in the short term, for this patient group. However, the FDA body maintains that information is lacking on the potential long-term benefits and risks of this procedure, particularly compared with open heart valve replacement surgery.
In this study, approximately 92 per cent of patients who received a percutaneous valve survived the procedure, of which 86 per cent survived for at least 30 days. The authors looked at 62 published studies representing a total of 856 patients, as well as additional studies that have not yet been published. However, researchers were unable to make direct comparisons between percutaneous valves and traditional surgical replacement due to differences between patient groups receiving the treatments.
In total, seven percutaneous valves were featured in the study, namely the Sapien transcatheter heart valve (Edwards), CoreValve ReValving system, Melody heart valve (Medtronic), Paniagu heart valve (Endoluminal Technology Research), Lotus valve (Sadra Medical) and Ventor Embracer (Ventor Technologies). This particular study didn’t look at the comparative performance of the devices, leaving that to be revealed through other studies currently in progress in the US. The AHRQ argues that there are plenty of comparative “mine’s better than yours” studies but little in the way of observational studies and decision modelling that could help inform clinical and health policy in the absence of randomised control trials.
It’s an important question since, as with most of the developed world, the US population proportion of older adults continues to increase, bring with it higher incidences of degenerative heart valve disease. Calcific aortic stenosis (narrowing) and ischaemic and degenerative mitral regurgitation (leakage) are the most common valvular disorders in adults aged 70 years and older.
Mechanical and, more latterly, bioprosthetic heart valves, have radically transformed the way in which we treat patients with heart disease. The urgent need now is to make sure that includes policymakers, decision makers for third-party payers, clinicians, patients and investigators, get the right form of information.
Thanks for reading, and come back soon, Paul.
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